patent digests 4.8.16

8/18/2019 Patent Digests 4.8.16

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could ,e u+ed a+ a t'eatment o' ;I< n *uman+! t*e appellant+ +a1! 6laxo7Wellcome

needed to 4no/ A:T /ould ,e a,+o',ed nto t*e *uman ,lood +t'eam! ma4e t+ /a1 to

t*e T2cell+ nected /t* ;I

?. The trial @udge re@ected the substance of this attac%, and declared certain of the claims to be valid and

infringed. The 7ederal $ourt of +ppeal, dismissed the appeal.

I++ue) 3hether the doctrine of sound prediction is applicable. A BC-.

;eld)

1. The evidence accepted by the trial @udge showed that by the date the U.;. patent was applied for,

9arch 1:, 18)*, laxo3ellcome had sufficient information about +T and its activity against /'0

in human cells to ma%e a sound prediction that +T would be useful in the treatment and prophylaxis

of /'0+'- in human beings. To the extent its claims went beyond the limits within which the

prediction remained sound, the 7ederal $ourt properly struc% them out.

2. The doctrine of “sound prediction” balances the public interest in early disclosure of new and useful

inventions, even before their utility has been fully verified by tests, and the public interest in avoiding

cluttering the public domain with useless patents and granting monopoly rights in exchange for

speculation or misinformation. W*le allo/n0 a patent ,a+ed on +peculaton /ould *ave ,een

una' to t*e pu,lc! 'eu'n0 6laxo7Wellcome to demon+t'ate A:T=+ ecac1 t*'ou0* t*e

clncal te+t+ 'eu'ed o' app'oval o a ne/ d'u0 o' medcal p'e+c'pton /ould *ave ,eenuna' to 6laxo7Wellcome. The disclosure made in the patent was and is of real use and benefit and

laxo3ellcome, by ma%ing the disclosure, fulfilled its side of the bargain with the public. 't was

therefore entitled to legal protection for what it disclosed.

. The $ommissioner


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!Eust in case you have time to spare, you can also read these"=

1. Unde' Unted State+ la/! t*e Cou't o Appeal+ o' t*e Fede'al C'cut +ad! t /a+ ''elevant

t*at 6laxo7Wellcome *ad no evdence o A:T=+ eectvene++ a0an+t t*e ;I)1. The Patent Act defines an “invention” as, amongst other criteria, “new and useful” !s. 2 ". 'f it is not

useful, it is not an invention within the meaning of the +ct.

2. It + mpo'tant to 'ete'ate t*at t*e onl1 cont',uton made ,1 6laxo7Wellcome n t*e ca+e o

A:T /a+ to dent1 a ne/ u+e. The compound itself was not novel. 'ts chemical composition had

been described 2H years earlier by r. /orwitD. laxo3ellcome claimed an unrecogniDed utility but

if it had not established such utility by tests or sound prediction at the time it applied for its patent,

then it was offering nothing to the public but wishful thin%ing in exchange for loc%ing up potentially

valuable research turf for !then" 1( years. +s observed in Procter ! "amble #o. v. Bristol-$%ers

#ana&a Lt&. !18(8", ?2 $.&.>. !2d" !7.$.+."=

+n “invention” includes a “new and useful process”. + “new” process is not an invention

unless it is “useful” in some practical sense. ;nowing a new process without %nowing its

utility is not in my view %nowledge of an “invention”.

. laxo3ellcome says the invention was complete when the draft patent application was circulated

internally on 7ebruary :, 18)*. It+ a'0ument *e'e! a+ n t*e Unted State+! /a+ t*at t*e /'tten

de+c'pton dented t*e d'u0 and t+ ne/ u+e +ucentl1 to 0ve t*e nventon dente and

p'actcal +*ape8. 't taught persons s%illed in the art how the invention could be practised.

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a. Iut -$ $anada said that the #uestion 7ebruary :, 18)*, was not whether the invention could be

practised but whether +T did the @ob against /'0 that was claimedJ in other words, whether

there was an% invention at all within the meaning of s. 21 of the Patent Act .

b. 'n #hristiani v. 'ice “it is not enough for a man to say that an idea floated through his brainJ he

must at least have reduced it to a definite and practical shape before he can be said to have

invented a process”. The claimed invention in that case was a process for manufacturing porous

cement. The utility of porous cement was not in dispute. The #uestion was how to ma%e it, and

who was the first to invent the process.

. In t*+ ca+e! D'. ;o'/t? tau0*t eve'1one *o/ to ma4e A:T. T*e ue+ton /a+ /*at

could u+eull1 ,e done /t* t.

c. 'n rnest *cragg ! *ons Lt&. v. Leesona #orp., the $ourt held that if the invention related to an

apparatus or process, it was sufficient if the apparatus had actually been built or the process used.

The invention in that case was for “Thermoplastic Barns and 9ethods of &rocessing Them.”

. A:T *ad ,een compounded and u+ed n @B! ,ut not ,1 6laxo7Wellcome! and not n

'elaton to ;I. 11H), at p. 111(, the prediction at the date of application

was not sound, or, irrespective of the soundness of the prediction, “FtGhere is evidence of lac% of

utility in respect of some of the area covered”.

9. ON SOUND PREDICTION

1. The evidence accepted by the trial @udge showed that by 9arch 1:, 18)*, laxo3ellcome had

sufficient information about +T and its activity against /'0 in human cells to ma%e a sound

prediction that +T would be useful in the treatment and prophylaxis of /'0+'- in human beings.

To the extent its claims went beyond the limits within which the prediction remained sound !e.g., inclaiming treatment for human retroviruses other than /'0", the 7ederal $ourt properly struc% them

out.

#. +lthough the trial @udge did not consider the doctrine of “sound prediction” to be applicable in this

sort of case, he seems to have applied it nevertheless when he decided that the claims did not exceed

the invention. /e also seems to have applied it when he upheld the patent claims for prophylaxis aswell as treatment. ;e +t'e++ed t*at demon+t'ated utlt1 o' 'educton to p'actce + not a

'eu'ement unde' Canadan patent la/8 "ac4 o demon+t'ated utlt1 doe+ not o,vate t*e

need o' +ound p'edcton.

. The doctrine of “sound prediction” was explicitly received into our law in Monsanto! by E. &igeon=

It cannot mean a ce'tant1 since it does not exclude all ris% that some of the area covered may

prove devoid of utility. 't thus appears to me that the test formulated ,1 6'a*am . nvolve+ -u+tt/o po++,le 'ea+on+ o' 'e-ectn0 clam+ +uc* a+ t*o+e n ++ue! /*c* a'e)

1. There is evidence of lac% of utility in respect of some of the area coveredJ ForG

2. 't is not a sound prediction.

1

2 F18HG -.$.>. ??.

F18:?G Cx. $.>. :?8.

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?. The 7ederal $ourt of +ppeal !in $anada" applied the doctrine of “sound prediction” in the context of

a patent for a pharmaceutical product in #iba-"eig% A" v. #ommissioner o+ Patents !18)2", :* $.&.>.

!2d" (. 'n that case, the $ourt upheld product and process claims in relation to certain “new amines”

useful in cardiac treatment, ,ut added t*at the predictability of chemical reactions should not,

however, be confused with predictability of the pharmacological effects and thus of the pharmacological utility of new substances.

a. This means that pharmacological utility cannot be predicted because predictability is

“essentially a #uestion of fact”. 't will depend on the evidence.

b. 'n Beecham "roup Lt&. v. Bristol Laboratories ,nternational *.A., F18()G >.&.$. *21 !/.K.",

for example, claims in respect of a semi6synthetic penicillin were invalidated as being little

more than an announcement of a research pro@ect. 't was held that=

The evidence in the instant case is overwhelming that it is not yet possible to predict in

advance what, if any, special therapeutic advantages will be possessed by a penicillin made

to a particular formula. T*e onl1 /a1 to nd out + to ma4e t and d+cove' /*at t+

t*e'apeutc c*a'acte'+tc+ a'e ,1 conductn0 exten+ve te+t+ upon t in vitro and in vivo.

*. /owever, where, as here, the trial @udge accepts on the evidence that the inventors coul& in fact ma%e

a sound prediction that an old compound !+T" offers a hitherto unexpected utility in the treatmentand prophylaxis of /'0+'-, then !and only then" does their disclosure of “the invention” offer real

consideration for the monopoly benefits they see%.

a. The doctrine of “sound prediction” balances the public interest in early disclosure of new and

useful inventions, even before their utility has been verified by tests !which in the case of

pharmaceutical products may ta%e years" and the public interest in avoiding cluttering the

public domain with useless patents, and granting monopoly rights in exchange for

misinformation.

:. T*e t'al -ud0e 'e-ected t*e +ound p'edcton n t*+ ca+e ,ecau+e n *+ ve/) the doctrine

addresses the issue of testing rather than utilit%. Thus the absence of tests confirming the suitability

of certain compounds was held not to be fatal !because the results were soundly predictable" in $onsanto itself, and in Burton Parsons #hemicals ,nc. v. elett-Packar& (#ana&a) Lt&., F18(:G 1

-.$.>. ***. The doctrine was used in those cases to permit the inventors to extrapolate from the

utility of a proven invention to the utility of e#uivalent chemical compounds. “+ccordingly”, the trial

@udge concluded at para. 88, “it would be inappropriate to rely on the doctrine of sound prediction

where the true cause of invalidity is not inutility but insufficient testing”.

%. T*e Reu'ement+ o t*e Doct'ne o Sound P'edcton8 &3 Component+(

1. T*e'e mu+t ,e a actual ,a++ o' t*e p'edcton.

a. 'n $onsanto and Burton Parsons, the factual basis was supplied by the tested compounds,

but other factual underpinnings, depending on the nature of the invention, may suffice.

2. T*e nvento' mu+t *ave at t*e date o t*e patent applcaton an a'tcula,le and +ound8

lne o 'ea+onn0 'om /*c* t*e de+'ed 'e+ult can ,e ne''ed 'om t*e actual ,a++.

a. 'n $onsanto and Burton Parsons, the line of reasoning was grounded in the %nown“architecture of chemical compounds” ! $onsanto, at p. 1118", but other lines of reasoning,

again depending on the sub@ect matter, may be legitimate.

. T*e'e mu+t ,e p'ope' d+clou+'e.

a. 5ormally, it is sufficient if the specification provides a full, clear and exact description of the

nature of the invention and the manner in which it can be practised.


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). 't bears repetition that the soundness !or otherwise" of the prediction is a #uestion of fact. Cvidence

must be led about what was %nown or not %nown at the priority date, as was done here. Cach case

will turn on the particularities of the discipline to which it relates. 'n this case, the findings of fact

necessary for the application of “sound prediction” were made and the appellants have not, in my

view, demonstrated any overriding or palpable error.

a. 4n 9arch 1, 18)*, laxo3ellcome received from the 5'/ the %ey results of thein vitro te+tof +T against the /'0 n a *uman cell lne. This, ta4en to0et*e' /t* laxo3ellcome5+ into 5+ and would thus prevent integration of the

viral genome into the genome of the hostJ

iii. Ioth 9K0 and /'0 were retrovirusesJ and

iv. laxo %new that +T would inhibit the replication of Ftwo strains of retrovirus in

mouse cellsG in 5ovember6ecember 18)?. Fpara. 2?8G

d. 4n receipt of the in vitro data from the 5'/ in 7ebruary 18)*, laxo3ellcome %new that

+T inhibits the replication of /'0 in a human cell line, albeit through in vitro rather than

through in vivo testing. T*e t'al -ud0e ound t*at n vt'o= te+t+ ma1 ,e adeuate /*ent*e a't /ould accept t*+ a+ app'op'atel1 co''elated /t* n vvo= utlt1 n *uman+.

e. 'n the trial @udge


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@@. 5ot all predictions, even sound ones, turn out to be correct. 'f the laxo3ellcome prediction had

subse#uently been shown to be wrong, the patent would have been invalidated for want of utility.

Iut, as &igeon E. remar%ed in $onsanto, “while the substances without utility had not been tested, the

true cause of the invalidity was the fact that they were without utility, not that they had not been

tested before the patent was applied for”.

C. 6"AO7WE""COGE=S AFTER2T;E2FACT


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appellants have demonstrated any palpable and overriding error with respect to this finding by the

trial @udge.

#. 'n sum, the 6laxo7Wellcome=+ p'edcton t*at t*e c*an te'mnato'8 eect d+clo+ed n t*e

patent +peccaton *ad p'op*1lactc a+ /ell a+ po+t2necton t'eatment applcaton /a+

+ound. T*e Comm++one' +o 'uled! and *+ dec+on to allo/ ,ot* t'eatment and p'op*1lax+

/a+ up*eld n t*e cou't+ ,elo/. T*e onu+ /a+ on t*e appellant+ to +*o/ t*at t*e patent +nvald! not on 6laxo7Wellcome to +*o/ t*at t + vald. I a0'ee /t* t*e t'al -ud0e and t*e

Fede'al Cou't o Appeal t*at t*e appellant+ *ave not d+c*a'0ed t*+ onu+.

5.USES OF EAGP"ES IN T;E SPECIFICATION

In re Strahilevitz

BBK F.#d @##! #@# U.S.P.L. 5B@ &C.C.P.A @K#(


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5.5 WRITTEN DESCRIPTION RELUIREGENT

G. Sell vs. Yap Jue,

@# P*l. 5@ &@$(


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Godines vs. CA!

##B SCRA 33K &@3(


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Frank vs. Kosuyama!

5 P*l #$B &@33(


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as!Cath, In". v. Mahhurkar,

35 F.#d @555! @ U.S.P.L.#d @@@@


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5.B "IGITATIONS ON AGENDGENTS

Sec. ! IP Code

Secton . Amen&ment o+ Application. 6 +n applicant may amend the patent application during

examination= &rovided, That such amendment shall not include new matter outside the scope of the

disclosure contained in the application as filed. !n"


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#he Gentry Gallery, In". v, #he $erkline Corp.,

@3 F.3d @%3 &Fed. C'. @K(


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5.% DEFINITE C"AIGS

%rthokineti"s v. Sa&ety #ravel Chairs, In".

K$B F.#d @5B5! @ U.S.P.L. #d @$K@ &Fed. C'. @KB(


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5. OWNERS;IP OF PATENT AND TRANSFER OF RI6;TS

Sec+. #K23$! IP Code

Secton #K. 'ight to a Patent . 6 The right to a patent belongs to the inventor, his heirs, or assigns. 3hen

two !2" or more persons have @ointly made an invention, the right to a patent shall belong to them @ointly.

!-ec. 1H, >.+. 5o. 1:*a"

Secton #. /irst to /ile 'ule. 6 'f two !2" or more persons have made the invention separately and

independently of each other, the right to the patent shall belong to the person who filed an application for

such invention, or where two or more applications are filed for the same invention, to the applicant who

has the earliest filing date or, the earliest priority date. !rd sentence, -ec. 1H, >.+. 5o. 1:*a."

Secton 3$. ,nventions #reate& Pursuant to a #ommission. 6 H.1. The person who commissions the wor%

shall own the patent, unless otherwise provided in the contract.

H.2. 'n case the employee made the invention in the course of his employment contract, the patent shall

belong to=

!a" The employee, if the inventive activity is not a part of his regular duties even if the

employee uses the time, facilities and materials of the employer.

!b" The employer, if the invention is the result of the performance of his regularly6assigned duties, unless

there is an agreement, express or implied, to the contrary. !n"

Sec+. B%2%$! IP Code

C;APTER


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!c" >e#uest that the application be refusedJ or

!d" -ee% cancellation of the patent, if one has already been issued.

:(.2. The provisions of -ubsection ).2 shall apply mutatis mutandis to a new application filed under

-ubsection :(. 1!b". !n"

Secton BK. 'eme&ies o+ the True an& Actual ,nventor . 6 'f a person, who was deprived of the patent

without his consent or through fraud is declared by final court order or decision to be the true and actual

inventor, the court shall order for his substitution as patentee, or at the option of the true inventor, cancelthe patent, and award actual and other damages in his favor if warranted by the circumstances. !-ec. ,

>.+. 5o. 1:*a"

Secton B. Publication o+ the #ourt 1r&er . 6 The court shall furnish the 4ffice a copy of the order or

decision referred to in -ections :( and :), which shall be published in the '&4 aDette within three !"months from the date such order or decision became final and executory, and shall be recorded in the

register of the 4ffice. !n"

Secton %$. Time to /ile Action in #ourt . 6 The actions indicated in -ections :( and :) shall be

filed within one !1" year from the date of publication made in accordance with -ections ?? and *1,respectively. !n"

Sec. #3B! IP Code

Secton #3B. Preservation o+ 2isting 'ights. 6 5othing herein shall adversely affect the rights on

the enforcement of rights in patents, utility models, industrial designs, mar%s and wor%s, ac#uired in good

faith prior to the effective date of this +ct. !n"


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patent digests 4.8.16

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